Device Classification Name |
electrocardiograph |
|||
---|---|---|---|---|
510(k) Number | K010955 | |||
Device Name | BMT ANSCORE HEALTH MANAGEMENT SYSTEM | |||
Original Applicant |
|
|||
Original Contact | cesidio tempesta | |||
Regulation Number | 870.2340 | |||
Classification Product Code |
|
|||
Date Received | 03/30/2001 | |||
Decision Date | 04/26/2001 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
Cardiovascular |
|||
510k Review Panel |
Cardiovascular |
|||
Type | Special | |||
Reviewed by Third Party | No | |||
Combination Product |
No |